Quality Management Senior Director

2 weeks ago


Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
About the Role:

The Senior Director Quality Operations will play a critical role in ensuring the site's compliance with CGMP regulatory requirements. This includes leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.

Responsibilities:
  1. Develop, implement, and maintain QA oversight activities to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
  2. Establish operational tier structure to ensure the site is continuously complying with standard operating procedures, processes, regulatory requirements, and partner commitments.
  3. Lead the Quality Operations team to deliver exceptional performance of each assigned area.
  4. Perform QA review and approval of any associated deviations, CAPAs, and change controls.
  5. Dispose products that meet all requirements on time based on established commitments.
  6. Liaise with internal and external stakeholders to achieve expected business outcomes.
Qualifications:
  • 12+ years of team management experience.
  • Bachelor's degree with 12+ years of relevant experience in a regulated pharmaceutical, biotechnology, or CDMO environment.
  • 7+ years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
  • Strong leadership, collaboration, team building, program management, and organizational skills.


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